Trials / Terminated
TerminatedNCT05672199
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Efavaleukin alfa | Subcutaneous (SC) injection |
| DRUG | Placebo | SC injection |
Timeline
- Start date
- 2023-04-28
- Primary completion
- 2024-10-31
- Completion
- 2024-10-31
- First posted
- 2023-01-05
- Last updated
- 2025-10-15
Locations
25 sites across 13 countries: United States, Argentina, Bulgaria, Denmark, Germany, Hungary, Japan, Mexico, Poland, Romania, South Korea, Switzerland, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05672199. Inclusion in this directory is not an endorsement.